United Kingdom onlyAbout Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
PositionOverview
The Lead Clinical Data Manager (LCDM) is accountable for clinical data management activities in support of the clinical pipeline for complex studies. This includes, but is not limited to, execution and ownership of the CDM operating model, oversight of internal staff (dotted line), and cross-functional leadership for the delivery of high quality and reliable clinical data to enable internal decision making, regulatory approval, and market acceptance. The LCDM interacts with senior level management, collaboration partners and provides cross functional strategic direction and is accountable for leading the data management activities for complex studies (i.e. Pearls) across functions to identify risks and opportunities as well as innovative approaches to clinical data management. The LCDM is critical to the success of our complex clinical trials and the integrity of data that supports regulatory submissions and decision-making.
KeyResponsibilities
Works closely with the Sr. Manager, Clinical Data Management / Analytics in buildinganefficient and compliantdata management function that meets industry standards andsupportsregulatory inspections.
Driving global data managementand data analyticsstrategy related to technologies and processes to increase efficiency,innovationand data qualityfor complex studies.
Leadsalldatamanagementaspectsfromstartuptodatabaselock,includingData Management Plans (DMP), Edit Checks, and Data Review Plans.
OverseesthedevelopmentandvalidationofElectronic Data Capture (EDC)systems,ensuringCDISCstandardsaremet.
Skills & Experience
Key competencies and characteristics neededto help build our diverse, inclusive culture and to be successful in the role. Examples include:
Overseeingthecollection,validation,processingandanalyzingofmorecomplexclinicaltrialdata.
Developingandimplementingdatamanagementanddataanalyticproceduresforclinicaltrials.
Supportingandfacilitatingthereviewofmedicalcodingforvalidityandcompleteness.
Ensuringcompliancewithapplicableregulations,protocolsandstandardoperatingprocedures.
Maintainthehighestdataqualitystandardsthroughoutthedatalifecycle,fromdatacollectiontodatabaselock.
Stayupdatedonindustrybestpractices,technologicaladvancementsandregulatoryrequirementsrelatedtoclinicaldatamanagementanddataanalytics.
Developandmaintaindatamanagementdocumentation,includingclinicalstudyprotocols,statisticalanalysisplans,casereportformsanddatamanagementplans.
Designcasereportforms(CRFs) and electronicdatacapture(EDC)systemsfordatacollection.
Performcleaningactivities,includingdiscrepancymanagementandqueryresolution.
Conductdatavalidationchecksandimplementqualitycontrolmeasurestoensureaccuracyandcompleteness.
Developandexecutestandardoperatingprocedures(SOPs)forapproval,dataentryscreen design andtesting,validationchecktestingandapproval.
Collaboratewithstudyteammemberstoresolvedata-relatedissuesanddiscrepancies.
Generate and reviewdatalistings,summariesandreportsforclinicalstudyreports.
Serveasaprimaryorbackupresourceforissuesaboutdatamanagement.
Ensurecompliancewithguidelines,GoodClinical Practice (GCP), CDISCstandardsandotherrelevantregulations.
Contributetothedevelopmentandvalidationofdatamanagementsoftwaretools.
OverseethedataanalyticsforConvatecclinicaltrialstoensuredataanalysesareperformedon time andwithinbudget.
CollaboratewithClinical Study Managers inleadingthedataanalyticsforthevariousclinicaltrialstoensurerobustanalysesareconductedperprotocolandtoidentifypatternsinthedata(trends)andimproveprocesses.
Qualifications/Education
Bachelor’s degree in a scientific or healthcare-related fieldor a computer science degree or equivalent professional certification.
4-6years of experience in clinical data management or a similar role in themedical deviceor clinical research industry.
Strong understanding of clinical trial processes, data managementprinciplesand regulatory guidelines.
Proficiencyin electronic data capture (EDC) systems(i.e. Veeva)and clinical data management software.
Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
Knowledge of industry-standard data analysis and reporting software, such as SAS,SQLand/or Oracle Clinical.
Excellent attention to detail with problem-solving and analytical skills.
Strong organisational and time management abilities.
TravelRequirements
Travel up to 5% of the timemay berequiredto attend departmental or company meetings whichmayrequire overnight travel; however, these meeting would be 1-2 times per year.
WorkingConditions
Remote Working
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
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